Ignite Creation Date:
2024-05-05 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001128
Status:
TERMINATED
Last Update Posted:
2016-12-14
First Post:
2000-01-17
Brief Title:
Treatment of Chronic Cryptosporidiosis in AIDS Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Proof-of-Concept Dose-Escalating Trial of Recombinant Human Interleukin-12 rhIL-12 Versus Placebo Along With Paromomycin and Azithromycin for Chronic Cryptosporidiosis in AIDS
Status:
TERMINATED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if it is safe and effective to add interleukin-12 IL-12 to the standard drug combination paromomycin plus azithromycin used to treat cryptosporidiosis in AIDS patients Doctors would like to find out if the combination of IL-12 paromomycin and azithromycin is more effective than paromomycin and azithromycin alone
Cryptosporidiosis is a type of opportunistic AIDS-related infection seen in HIV-positive patients as their immune systems weaken It is caused by a parasite that invades the intestinal tract and it can cause watery diarrhea stomach cramps an upset stomach or a fever Antibiotics paromomycin and azithromycin are usually used to treat cryptosporidiosis In this study doctors will look at the effectiveness of using IL-12 IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis
Cryptosporidiosis is a type of opportunistic AIDS-related infection seen in HIV-positive patients as their immune systems weaken It is caused by a parasite that invades the intestinal tract and it can cause watery diarrhea stomach cramps an upset stomach or a fever Antibiotics paromomycin and azithromycin are usually used to treat cryptosporidiosis In this study doctors will look at the effectiveness of using IL-12 IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis
Detailed Description:
Cryptosporidium parvum an intracellular protozoan parasite is a frequent cause of chronic diarrhea in HIV-infected patients causing significant morbidity and mortality Highly effective antiparasitic treatment for this infection is not currently available Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients Immune reconstitution with highly active antiretroviral therapy appears to be the most effective therapy but this is not possible for all patients Interferon gamma expression is strongly associated with control of cryptosporidiosis and IL-12 is the cytokine primarily responsible for stimulation of interferon gamma expression in vivo It is hoped that treatment with recombinant human IL-12 can result in stimulation of an intestinal cytokine response in AIDS patients with cryptosporidiosis and that response combined with chemotherapy can lead to the elimination of detectable numbers of Cryptosporidium oocysts from the stools
All patients receive azithromycin and paromomycin and patients are randomized to add either IL-12 or placebo IL-12 or placebo injections are given twice a week Patients take their study medications for 4 weeks During this time they will be asked to record bowel movements and any symptoms they experience Patients return to the clinic at least twice a week to receive IL-12 or placebo injections At Weeks 2 and 4 patients are seen by one of the principal investigators Blood samples are obtained for viral load measurements and CD4 count as well as routine urinalysis Patients undergo upper endoscopy with jejunal biopsy and colonoscopy with ileal biopsy between Weeks 2 and 4 of therapy for assays of intestinal cytokine expression A final clinic visit occurs 12 weeks post-therapy for a physical exam and blood tests
All patients receive azithromycin and paromomycin and patients are randomized to add either IL-12 or placebo IL-12 or placebo injections are given twice a week Patients take their study medications for 4 weeks During this time they will be asked to record bowel movements and any symptoms they experience Patients return to the clinic at least twice a week to receive IL-12 or placebo injections At Weeks 2 and 4 patients are seen by one of the principal investigators Blood samples are obtained for viral load measurements and CD4 count as well as routine urinalysis Patients undergo upper endoscopy with jejunal biopsy and colonoscopy with ileal biopsy between Weeks 2 and 4 of therapy for assays of intestinal cytokine expression A final clinic visit occurs 12 weeks post-therapy for a physical exam and blood tests
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: